menopause transition period:Ovarian function decline
Conditions
Interventions
treatment group:Yangyinshugan capsule
placebo controled group:placebo
Sponsors
Guangdong Provincal hospital of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
39 Years to 43 Years
Inclusion criteria
Inclusion criteria: Diagnostic criterion According to ,2014, People's Medical Publishing House and Stage of Reproductive Aging Workshop(STRAW) :early stage of menopause transition period: over 7 days change of two consecutive menstrual cycle, which can accompany with the FSH rise. TCM syndrome criterion: Kidney deficiency and liver stagnation syndrome.According to ,2012,Chinese Medicine Publishing House of China Inclusion criterion: 1. Meet the diagnostic criterion; 2. Age from 39-43 years; 3. Change of Menstrual cycle; 4. Did not use any of the following treatment for at least 3 months before entry into the study: hormone therapy, selective elective estrogen receptor modulators, aromatase inhibitors, soybean extracts or Chinese medicine; 5. Singed informed consent voluntary.
Exclusion criteria
Exclusion criteria: 1. Menstrual cycle delayed over 2 cycles(60days) 2. Menstrual disorder caused by other endocrine disease, such as hyperprolactinemia, polycystic ovary syndrome and thyroid disease etc; 3. History of gynecological operation, such as shelling out the ovarian cyst, ovarian drilling technique, ovarian wedge resection, adnexectomy, tubal resection and tubal ligation and operation of pelvic abscess, uterine artery embolization etc; 4. Reproductive toxicity drug used, such as Lei Gongteng, Kunming mountain Chinese flowering apple, torch flower root tablet, chemotherapy medicine etc; 5. Family history of premature ovarian failure; 6. Hormone therapy used for at least 3 months before entry into the study; 7. Pregnancy women or lactation women; 8. Uncontrolled and/or diagnosed internal medical conditions that are likely to interfere with or influence study treatment, eg, hepatic or renal dysfunction; thrombophlebitis; thrombotic diseases;Cerebrovascular disease; Myocardial infarction, or ischemic heart disease; gallbladder disease; diabetes mellitus requiring medical treatment; Uncontrolled or untreated hypertension (defined as systolic blood pressure higher than 160 mm Hg and/or diastolic blood pressure higher than 100 mm Hg); thyroid disease; 9. Patients with Serious mental illness; 10. Joined other Phase I and II clinical trials 6 months before or Phase III or IV clinical trials 3 months before; 11. Known or suspicious gynecological reproductive system cancer ;or known or suspicious breast cancer; 12. Allergic constitution or Allergic to trial medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM Syndromes scale of menstrual disorders;FSH, E2, Anti-Mullerian Hormone, inhibin B;pelvic b ultrasoud: ovary volume, AFC; | — |
Countries
Chine
Contacts
Public ContactXiaoyun Wang
Outcome results
None listed